US FDA clears Spineart Juliet Ti lumbar interbody devices

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Spineart logo

Spineart has received 510(k) clearances from the US Food and Drug Administration to market its new Juliet Ti lumbar interbody systems in the USA. The Juliet Ti PO, OL and TL interbody systems are the first range of titanium interbody implants incorporating the company’s proprietary Ti-Life technology.

The Ti-Life technology micro-porous scaffold is designed to mimic the bone trabecular structure and features interconnected pores of 600μm to 700μm and an overall porosity of 70-75% designed to enable cell colonisation and promote bone in-growth. According to a company relese, this technology is based on a unique algorithm associated with a state-of-the-art additive manufacturing process.

The Juliet Ti interbody systems for PLIF, OLIF and TLIF techniques include a full range of sizes to address different anatomies as well as an insert-rotate option. The smooth bullet-shaped nose, lateral sides and chamfers of the implant are polished with the intention of preserving endplates, nerve roots and soft tissues during insertion. The product design features an overall reduced density, intended to optimise the imaging performances. Spineart announced that the products were CE marked in July 2016.